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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K170708
Device Name OWL RF INSULATED CANNULAE
Applicant
Diros Technology, Inc.
120 Gibson Dr.
Markham,  CA L3R 2Z3
Applicant Contact Ron Baker
Correspondent
Diros Technology, Inc.
120 Gibson Dr.
Markham,  CA L3R 2Z3
Correspondent Contact Ron Baker
Regulation Number882.4725
Classification Product Code
GXI  
Date Received03/08/2017
Decision Date 06/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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